MSPGH Special Seminar: 6th February 2018 – Biostatistical Contributions to the Planning of Clinical Trials: Examples from Three Studies

Professor Andreas Ziegler, Institute of Medical Biometry and Statistics, University of Lübeck, Germany

Proper methodological planning and excellent logistics are key to success or failure of clinical trials. In this presentation, Professor Ziegler will illustrate the impact of biostatistical planning on clinical trials using three randomized controlled trials as examples. The first example deals with precision medicine in Parkinson’s disease and involved the use of time-dependent regression models for assessing the gradient of response with genetic status. In the second example, he considers a trial of insulin pumps in children and adults with type 1 diabetes and shows how sample size was re-estimated using information on variation between age strata. In the final example, a trial of biodegradable metal-based screws for surgical procedures, they consider approaches to testing for non-inferiority.